Researchers Identify a Simple Inexpensive Drug Regimen which is Highly Effective in Preventing HIV in Infants of Mothers with the Disease

JUL-13-1999 13:10 OD/NIAID/NIH 3014964409 P. 03/04
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Nevirapine was markedly more effective. At 14 to 16 weeks of age, 13.1 percent of
infants who received nevirapine were infected with HIV, compared with 25.1 percent of those in
the AZT group.
"In this study, the short-course nevirapine regimen resulted in a 47 percent reduction in
mother-to-infant HIV transmission compared with a short course of AZT. The implications of
this study for developing countries, where 95 percent of the AIDS epidemic is occurring, are
profound," says Brooks Jackson, M.D., the lead US. investigator on the trial. If the shortcourse regimen of AZT is more effective than placebo, the risk reduction of this nevirapine
regimen relative to placebo would be even greater.
Long-term follow-up of both the mothers and their babies remains a high priority to
assess any late drug toxicities as well as long-term survival. The mothers and their children will
continue to be actively followed until the babies are 18 months old. This period is critical to
establish the efficacy of the intervention because even if a baby is bom HIV-free, he or she may
acquire the virus during breastfeeding. The data analyzed so far cover only the first three
months of the newborn's life. Ugandan and U.S. investigators will soon launch a follow-up
study to evaluate the efficacy of nevirapine administered to the mother during labor and to the
newborns for a longer period of time.
Breastfeeding is practiced widely in developing countries. Most studies indicate that the
rate of -IlV transmission via breastfeeding is highest in the first few months of life. No
intervention has yet been shown to prevent HIV transmission through breast milk other than not
breastfeeding.
The single-dose nevirapine regimen to mother and infant substantially lowers the cost
barrier that has kept many countries from adopting drug strategies that prevent perinatal MINI
transmission. Still, access to other health care services that need to be considered in
implementing this regimen, such as counseling and voluntary MINI testing, currently is out of
reach in many developing countries. But if further research upholds nevirapine's good safety
record, the investigators say that potentially all pregnant wromen who live In areas of high HINI

prevalence could receive the drug during labor, even in the absence of an established HIV
diagnosis.